CN100337701C - Endoprosthesis - Google Patents

Abstract

The present invention provides an endoprosthesis, generally referred to as a stent, comprising a main body, an elastic portion, a plurality of anchoring portions and a connecting portion containing connecting elements. The stent is designed to be firmly fixed in a body lumen of a patient regardless of changes in the form of the body lumen such as an airway, thereby improving the stability of the stent and increasing the durability of the stent by flexibly maintaining the conformity with the operating state of the body lumen such as an airway.

Description

Translated fromChinese

内用假体Endoprosthesis

技术领域technical field

本发明涉及一种内用假体，通常称为支架，具体讲，该支架被设计用于牢固地固定在病人的体腔内，而无论体腔例如气道的形态如何变化，因此，通过灵活地与体腔例如气道的活动状态保持一致而提高支架的稳定性和增加它的耐用性。The present invention relates to an endoprosthesis, commonly referred to as a stent, in particular, which is designed to be securely fixed in a body cavity of a patient regardless of the shape of the body cavity such as the airway The active state of the body cavity, such as the airway, remains consistent to enhance the stability of the stent and increase its durability.

背景技术Background technique

通常，体腔狭窄例如气道狭窄根据解剖学上受损部分划分经常分为内腔阻塞，外部压迫和软化症。内用假体，即用于扩张变窄的体腔通道例如气道的支架，已经用于治疗病人的呼吸困难，这种呼吸困难是由于外部压迫和软化症的气道狭窄而导致的。In general, body cavity stenosis such as airway stenosis is often divided into luminal obstruction, external compression and malacia according to the anatomically damaged part. Endoprostheses, ie stents used to dilate narrowed body cavity passages such as airways, have been used to treat patients with dyspnea due to external compression and narrowing of the airways in malacia.

这种类型的支架通常具有圆柱形的结构，并且以金属和/或硅树脂橡胶制成网眼型。通常，可自我扩张的支架已经被广泛的应用，该支架在外力作用下可收缩，并且当它处于无外力的无负荷状态下能够自然地处于扩张状态。这样的支架通过使用支架置入设备可以被放在体腔变窄的区域处。Stents of this type usually have a cylindrical structure and are made of metal and/or silicone rubber mesh. In general, self-expandable stents have been widely used, which can be contracted under the action of external force, and can be naturally expanded when it is in a no-load state without external force. Such a stent can be placed at the narrowed area of the body lumen by using a stenting device.

为了能够正常地发挥功能，自我扩张支架必须具有某些特性，例如，以预定的力来扩张体腔的扩张性，根据体腔的弯曲构型而灵活弯曲的适应性，固定在被放入体腔内的位置的稳定性，和在小于预定大小的时能够收缩的可收缩性。In order to function properly, self-expanding stents must have certain properties, such as expandability to expand the body lumen with a predetermined force, adaptability to bend flexibly according to the curved configuration of the body lumen, fixation in the Stability in position, and shrinkability to shrink when smaller than a predetermined size.

Giantruco的美国Pat.No.4,580,568和Wallsten的美国Pat.No.4,655,771中公开了金属自我扩张支架的例子。Examples of metal self-expanding stents are disclosed in US Pat. No. 4,580,568 to Giantruco and US Pat. No. 4,655,771 to Wallsten.

金属自我扩张支架例如Giantruco支架和Wallsten支架能够轻易地置于体腔例如气道内，并且可以进一步扩张体腔而不必麻醉病人。然而，由于难以在体腔的变窄的区域内重新定位金属支架或者将它从变窄的的区域取走，所以金属支架主要用于恶性的气道阻塞。Metallic self-expanding stents such as the Giantruco stent and the Wallsten stent can be easily placed in a body lumen, such as an airway, and can further dilate the lumen without anesthetizing the patient. However, metal stents are mainly used for malignant airway obstruction due to the difficulty in repositioning the metal stent in or removing it from the narrowed area of the body lumen.

也就是说，尽管金属自我扩张支架由于减小了插入设备的直径而具有易于放入体腔变窄的区域内的优点，但是金属自我扩张支架具有本质上的缺点，即由于组织在支架的金属细丝之间生长而引起再狭窄。That is, although metal self-expanding stents have the advantage of being easy to be placed in narrowed regions of body lumens due to the reduced diameter of the insertion device, metal self-expanding stents have inherent disadvantages in that the metal finer points of the stent are trapped by tissue. Growth between filaments causes restenosis.

为了解决这个问题，金属支架被覆上聚合体材料，从而预防组织在其中生长。相应地，也能够预防体腔的再狭窄，并且金属支架能够容易地、安全地置入体腔的变窄的区域内。然而，由于金属支架不能牢固地固定到体腔例如气道内部，所以它仍然有容易到处移动的缺点。To solve this problem, metal stents are coated with a polymer material that prevents tissue growth within them. Accordingly, restenosis of the body cavity can also be prevented, and the metal stent can be easily and safely placed in the narrowed area of the body cavity. However, the metal stent still suffers from the disadvantage of being easily moved around since it cannot be securely fixed inside a body cavity such as an airway.

就是说，为了预防由于支架内部的组织生长而引起的再狭窄，需要用聚合体材料覆盖金属支架。但是，在这种情形下，支架容易从体腔的变窄的区域移走，从而导致用来防止体腔狭窄的最初的目的不能实现。That is, in order to prevent restenosis due to tissue growth inside the stent, it is necessary to cover the metal stent with a polymer material. However, in this case, the stent is easily dislodged from the narrowed region of the body lumen, thereby defeating the original purpose of preventing the narrowing of the body lumen.

此外，由于大多数硅树脂支架只有圆柱形的结构，这样的支架由于其尺寸大而难以置于体腔例如气道的内部，并且难以牢固地固定到体腔内，因此极大的降低了他们的稳定性。In addition, since most silicone stents have only a cylindrical structure, such stents are difficult to place inside body cavities such as airways due to their large size, and are difficult to be firmly fixed in body cavities, thus greatly reducing their stability. sex.

同样，由于这种具有自我扩张特性的单一的共轴圆柱形结构，用于扩张体腔变窄的通道的支架并不能对气道的构型变化产生灵活的反应，其中这种具有气道狭窄的构型由于病人咳嗽等此类情况发生非常大的变化，因而极大地降低了支架的耐用性。Also, due to the single coaxial cylindrical structure with self-expanding properties, stents used to dilate narrowed passages in body lumens do not respond flexibly to configuration changes in airways, such as those with narrowed airways. The configuration changes quite a lot due to things like a patient coughing etc., which greatly reduces the durability of the brace.

也就是说，当由于狭窄症病人咳嗽导致气道发生明显变化的时候，支架截面的形状没有以C形折叠，该C形与改变的气道构型中的支架具有相同的曲率中心。支架没有折叠的部分抵抗气道构型的变化力，从而承受巨大的压力作用导致支架容易断裂。相应地，支架的耐用性大大降低。That is, when the airway is significantly changed due to the cough of a stenosis patient, the cross-sectional shape of the stent is not folded in a C-shape having the same center of curvature as the stent in the altered airway configuration. The unfolded part of the stent resists the changing force of the airway configuration, and thus bears a huge pressure, which makes the stent easy to break. Accordingly, the durability of the stand is greatly reduced.

发明内容Contents of the invention

因此，本发明构思致力于解决传统支架中存在的上述问题。Therefore, the present inventive concept aims to solve the above-mentioned problems existing in conventional stents.

本发明的目的是提供一种内用假体，通常称作支架，该支架被设计为能够被牢固地固定在病人的体腔内，而无论体腔例如气道的构型如何变化，因此通过与体腔例如气道的活动状态灵活地保持一致而提高支架的稳定性和增加它的耐用性。It is an object of the present invention to provide an endoprosthesis, commonly referred to as a stent, which is designed to be securely fixed in a patient's body cavity regardless of the configuration of the body cavity, such as the airway, so that by interacting with the body cavity For example, the active state of the airway is flexibly maintained to improve the stability of the stent and increase its durability.

为了实现以上目的，本发明的一个实施例提供一种支架，该支架包括一个主体，该主体在外力作用下能够收缩，并且当它处于无外力的无负荷状态下能够自然地处于扩张状态，该主体有预定的长度和形状，还包括弹性部分，弹性部分用于通过把主体的两端彼此连接与而主体一起形成其间的通道，弹性部分还能使主体灵活地适应体腔例如气道构型的变化。支架还可以包括多个固定部分，用于将主体牢固的固定到体腔例如气道的变窄的区域，固定部分位于主体的外表面。支架还可以包括连接部分，该连接部分用于把一个支架同其它的支架连接，并且不需要有进一步的处理、操作以及设备的协助就能保持它的特性，连接部分以预定的大小形成于支架的末端。In order to achieve the above object, one embodiment of the present invention provides a stent, which includes a main body, which can shrink under the action of an external force, and can be naturally expanded when it is in a no-load state without external force, the stent The main body has a predetermined length and shape, and also includes an elastic portion, which is used to form a channel between the two ends of the main body by connecting the two ends of the main body with the main body. Variety. The stent may also include a plurality of fixing parts for firmly fixing the main body to a narrowed area of a body cavity such as an airway, the fixing parts being located on the outer surface of the main body. The stent may also include connecting portions for connecting one stent to other stents and retaining its properties without further handling, manipulation, and equipment assistance, the connecting portions being formed on the stents in a predetermined size the end.

因为具有这样的结构，当将按照本发明实施例中的支架置于体腔例如气道的变窄的区域内时，支架主体的自我扩张性扩张气道的变窄的区域，主体和弹性部分内部之间的通道被用来作为气道的通道，并且固定部分在气道的变窄的区域内牢固地固定支架。Because of this structure, when the stent according to the embodiment of the present invention is placed in a narrowed area of a body cavity such as an airway, the self-expandability of the stent main body expands the narrowed area of the airway, and the inside of the main body and the elastic portion The channel in between is used as a channel for the airway, and the fixing part securely fixes the stent in the narrowed area of the airway.

附图说明Description of drawings

图1为根据本发明第一个实施例的支架的透视图；1 is a perspective view of a bracket according to a first embodiment of the present invention;

图2为根据本发明第一个实施例的支架的纵切面图；Fig. 2 is a longitudinal sectional view of a bracket according to a first embodiment of the present invention;

图3为根据本发明第一个实施例的支架处于折叠状态时的透视图；Figure 3 is a perspective view of the stand in a folded state according to the first embodiment of the present invention;

图4为图3所示支架的纵切面图；Fig. 4 is a longitudinal sectional view of the bracket shown in Fig. 3;

图5为根据本发明第一个实施例的支架处于连接状态时的横切面图；5 is a cross-sectional view of the bracket in a connected state according to the first embodiment of the present invention;

图6为图5中A部分的放大图；Fig. 6 is an enlarged view of part A in Fig. 5;

图7为根据本发明第二个实施例中的支架的透视图；7 is a perspective view of a bracket according to a second embodiment of the present invention;

图8为根据本发明第二个实施例中的支架的纵切面图；Figure 8 is a longitudinal sectional view of a bracket according to a second embodiment of the present invention;

图9为根据本发明第二个实施例中的支架的侧面图。Fig. 9 is a side view of a bracket according to a second embodiment of the present invention.

具体实施方式Detailed ways

本发明的优选实施例在下文中结合相应的附图将做更详细的描述。Preferred embodiments of the present invention will be described in more detail below with reference to the corresponding drawings.

参考图1至图6，根据本发明第一个实施例的支架10包括主体11，该主体有预定长度和形状并且该主体在外力作用下能够收缩，而当它处于无外力的无负荷状态下能够自然地处于扩张状态，还包括弹性部分13，弹性部分用于通过把主体11的两端彼此连接与而主体11一起形成其间的通道。Referring to FIGS. 1 to 6, astent 10 according to a first embodiment of the present invention includes amain body 11, which has a predetermined length and shape and which can shrink under an external force, and when it is in a no-load state without an external force Capable of being naturally expanded, it also includes anelastic portion 13 for forming a channel therebetween by connecting the two ends of themain body 11 to each other.

保持预定弹性的弹性部分13可以根据体腔例如气道的构型变化而使主体弯曲。Theelastic portion 13 maintaining a predetermined elasticity can bend the main body according to a configuration change of a body cavity such as an airway.

对应于如图1所示的弹性部分，主体部分11可具有半圆柱形结构。然而，本发明并不仅限于此。也就是，主体11可以具有另外的结构，如圆柱形结构。Corresponding to the elastic portion as shown in FIG. 1 , themain body portion 11 may have a semi-cylindrical structure. However, the present invention is not limited thereto. That is, themain body 11 may have another structure, such as a cylindrical structure.

支架10包括多个固定部分15，固定部分15位于主体11的外表面上。固定部分将主体11牢固地固定到体腔例如气道的变窄的区域。Thestand 10 includes a plurality offixing portions 15 located on the outer surface of themain body 11 . The fixing portion firmly fixes themain body 11 to a narrowed area of a body cavity such as an airway.

此外，支架10包括连接部分，该连接部分用于把一个支架同其它的支架连接，这样它可以用于体腔例如气道的长的变窄的区域或弯曲区域。连接部分具有预定的大小位于支架10的末端。连接部分至少连接一个支架，同时无须进一步的处理、操作以及设备的协助就能保持它的特性。Furthermore, thestent 10 includes connecting portions for connecting one stent to the other so that it can be used in long narrowed or curved regions of body lumens such as airways. The connecting portion has a predetermined size and is located at the end of thebracket 10 . The connection part connects at least one support while retaining its characteristics without the aid of further handling, manipulation and equipment.

主体11的横切面可以近似于半圆形或圆形；优选为C形结构，因而当体腔如气道的构型发生变化时，弹性部分可以易于折叠。The cross-section of themain body 11 can be approximately semicircular or circular; it is preferably a C-shaped structure, so that when the configuration of the body cavity such as the airway changes, the elastic part can be easily folded.

此外，优选主体11由具有自我扩张特性和预定外形的材料制成，例如硅，橡胶和聚合体。为了有效的适应弯曲体腔的变窄的区域，优选主体11应该具有弹性。为了将主体11收缩到小于预定尺寸以插入体腔例如气道的变窄的区域内，优选主体11也应该具有收缩性。In addition, it is preferable that themain body 11 is made of a material having self-expanding properties and a predetermined shape, such as silicon, rubber and polymer. In order to effectively adapt to the narrowed area of the curved body cavity, preferably themain body 11 should be elastic. In order to shrink thebody 11 to less than a predetermined size for insertion into a narrowed region of a body cavity such as an airway, preferably thebody 11 should also have shrinkability.

主体11优选应该具有预定的弹性，这样通过弹性部分的作用它能够被有效的折叠。Themain body 11 should preferably have predetermined elasticity so that it can be effectively folded by the action of the elastic portion.

优选弹性部分13主要为平面形，为了易于将支架置于体腔内，它与主体11一起可自动收缩和扩张，并且它用与主体11同样的材料整体地制成。It is preferable that theelastic part 13 is mainly planar, and it can be automatically contracted and expanded together with themain body 11 for easy placement of the stent in the body cavity, and it is integrally made of the same material as themain body 11.

此外，弹性部分13可以与主体11整体地形成，它可以与主体11有相同的或者不同的厚度。In addition, theelastic portion 13 may be integrally formed with themain body 11, and it may have the same or different thickness from themain body 11.

优选弹性部分13的弹性大于主体11，这样它可以被灵活的改变，也就是，可以根据气道的构型变化而折叠。更优选弹性部分13的厚度低于主体11。Preferably, the elasticity of theelastic portion 13 is greater than that of themain body 11, so that it can be changed flexibly, that is, it can be folded according to the configuration of the airway. More preferably, the thickness of theelastic portion 13 is lower than that of themain body 11 .

此外，弹性部分13沿它的宽度可以具有相同或不同的厚度。优选弹性部分13的厚度随着它沿中心线的纵向向内接近而逐渐变小，这样它可以根据体腔构型的变化而容易折叠。Furthermore, theelastic portion 13 may have the same or different thicknesses along its width. Preferably, the thickness of theelastic portion 13 becomes gradually smaller as it approaches longitudinally inwardly along the centerline, so that it can be easily folded according to changes in the configuration of the body cavity.

优选弹性部分13在根据体腔构型变化而折叠的时候以与主体11相同的半径中心折叠。It is preferable that theelastic portion 13 is folded at the same radius center as that of themain body 11 when folded according to the body cavity configuration change.

优选固定部分15具有硬度，当有外部压力作用于支架10的主体11和弹性部分13的时候，固定部分15不被压碎，并且当外力撤销的时候，他们可以恢复支架10的原始形状。It is preferable that thefixed part 15 has hardness, and when external pressure acts on themain body 11 and theelastic part 13 of thebracket 10, the fixedpart 15 is not crushed, and when the external force is removed, they can restore the original shape of thebracket 10.

优选固定部分15与主体整体上组合在一起，且以与主体和弹性部分相同的材料制成。Preferably the fixingpart 15 is integrally combined with the main body and made of the same material as the main body and the elastic part.

此外，固定部分15可以沿主体圆周方向从整个或部分圆周表面突出，以便将主体11牢固地固定到体腔的变窄的区域。In addition, the fixingportion 15 may protrude from the entire or part of the circumferential surface of the main body in the circumferential direction of the main body in order to firmly fix themain body 11 to the narrowed area of the body cavity.

固定部分15可以具有与主体11相同的半径中心，以便能够与主体11一起对体腔的构型变化产生灵活的反应。固定部分15的切面具有预定的形状；优选为矩形以便更牢固地固定主体11。The fixingpart 15 may have the same radius center as themain body 11, so as to be able to flexibly respond to configuration changes of the body cavity together with themain body 11. The cut surface of the fixingpart 15 has a predetermined shape; preferably rectangular in order to fix themain body 11 more firmly.

并且，固定部分15可以在主体11的外表面沿纵向均匀地或以任意的距离形成，并且它们也可以在主体11的外表面沿径向均匀地或以任意距离形成。Also, the fixingportions 15 may be formed uniformly or at any distance in the longitudinal direction on the outer surface of themain body 11 , and they may also be formed uniformly or at any distance in the radial direction on the outer surface of themain body 11 .

固定部分15突出的高度可以与主体11外表面的高度相同，也可以不同。The protruding height of the fixingportion 15 may be the same as or different from the height of the outer surface of themain body 11 .

优选固定部分15之间形成间隔区域200，以便当主体11被置于体腔例如气道的变窄的区域内时，通过嵌入主体11的组织将主体更牢固地固定到体腔。Aspacer region 200 is preferably formed between the fixingportions 15 to more firmly fix the body to the body cavity by the tissue embedded in thebody 11 when thebody 11 is placed in a narrowed area of the body cavity such as an airway.

此外，连接部分位于支架的一端和另端。连接部分包括凹面和凸面连接元件17，18，19和20，它们用于将支架的一端部分和另端部分分别连接到其它支架的的另端部分和一端部分。In addition, connecting portions are located at one end and the other end of the bracket. The connecting portion comprises female andmale connecting elements 17, 18, 19 and 20 for connecting one end portion and the other end portion of the bracket to the other end portion and the one end portion of the other bracket respectively.

当体腔例如气道的变窄的区域较长的时候，连接部分可以被用于沿变窄的区域的长度连接多个支架。When the narrowed region of a body lumen, such as an airway, is long, the connecting portion may be used to connect multiple stents along the length of the narrowed region.

优选，连接部分用具有弹性的材料制成，这样当它被置于体腔例如气道的变窄的区域的弯曲区域内时，能够有效的适应体腔的弯曲程度。优选连接部分以与主体和弹性部分相同的材料整体制成。Preferably, the connecting portion is made of elastic material so that it can effectively adapt to the curvature of the body cavity when it is placed in the curved region of the narrowed region of the body cavity such as the airway. Preferably the connecting portion is integrally made of the same material as the main body and elastic portion.

优选凹面和凸面连接元件17，18，19和20以具有预定形状和自我扩张特性的材料制成，以便能够容易的彼此连接。Preferably the female andmale connecting elements 17, 18, 19 and 20 are made of a material having a predetermined shape and self-expanding properties so as to be easily connected to each other.

凹面连接元件17和18和凸面连接元件19和20分别位于支架10的主体11和弹性部分13的一端部分和另端部分。Thefemale connecting elements 17 and 18 and themale connecting elements 19 and 20 are respectively located at one end portion and the other end portion of themain body 11 and theelastic portion 13 of thebracket 10 .

这样，优选凸面连接元件19和20的内直径与主体11和弹性部分13的直径基本相同，这样能够牢固地安装支架，凹面连接元件17和18的外直径与凸面连接元件19和20的外直径基本相同，这样能够牢固地安装支架。Like this, preferably the inner diameter of male connectingelement 19 and 20 is substantially the same as the diameter ofmain body 11 andelastic portion 13, can install support firmly like this, the outer diameter of female connectingelement 17 and 18 and the outer diameter of male connectingelement 19 and 20 Essentially the same, this allows for secure mounting of the stand.

此外，凹面连接元件17的内表面上有制动器23，用于将凹面连接元件17限制在凸面连接元件19的末端，这样就预防凸面连接元件19移动到处于耦合状态的凹面连接元件17的内侧，在耦合状态中其它支架的凸面连接元件19连接到这个凹面连接元件17。In addition, there arestoppers 23 on the inner surface of the female connectingelement 17 for limiting the female connectingelement 17 to the end of themale connecting element 19, thus preventing themale connecting element 19 from moving to the inside of the female connectingelement 17 in the coupled state, Themale connection element 19 of the other carrier is connected to thisfemale connection element 17 in the coupled state.

制动器23沿凹面连接元件17内表面的一个末端从它的内表面向内侧突出。优选制动器23与主体11组合成一个整体。Astopper 23 protrudes inwardly from its inner surface along one end along the inner surface of thefemale coupling member 17 . Preferably thebrake 23 is integrated with themain body 11 .

分别在凹面连接元件18的内表面和凸面连接元件20的外表面形成连接凹槽25和27。连接凹槽25和27分别把凸面和凹面的连接元件20和18与凹面和凸面连接元件18和20结合为耦合状态，在耦合状态中凹面和凸面连接元件18和20彼此结合。连接凹槽25和27以预定的大小凹入形成。Connection grooves 25 and 27 are formed on the inner surface of thefemale connection member 18 and the outer surface of themale connection member 20, respectively. Theconnection grooves 25 and 27 respectively combine the male andfemale connection elements 20 and 18 with the concave andconvex connection elements 18 and 20 into a coupled state in which the concave andconvex connection elements 18 and 20 are bonded to each other. Theconnection grooves 25 and 27 are concavely formed with a predetermined size.

优选连接槽25具有形成从凹面连接元件18的内表面向其外方向形成的并且具有预定的厚度的梯级。优选连接槽27具有形成从凸面连接槽20的外表面向其内方向形成的并且具有预定的厚度的梯级。It is preferable that theconnection groove 25 has a step formed from the inner surface of theconcave connection member 18 toward its outer direction and has a predetermined thickness. It is preferable that the connectinggroove 27 has a step formed from the outer surface of the convex connectinggroove 20 toward its inward direction and has a predetermined thickness.

如此，通过使用支架插入设备，本发明第一个实施例的支架10被置于体腔例如气道的变窄的区域内。然后，气道的变窄的区域通过支架10的主体11的自我扩张而被扩张。因此，当主体11被放在气道的变窄的区域时，在主体11和弹性部分13内侧形成通道100，用作气道通道。Thus, by using the stent insertion device, thestent 10 of the first embodiment of the present invention is placed in a narrowed region of a body cavity such as an airway. The narrowed area of the airway is then expanded by the self-expansion of thebody 11 of thestent 10 . Therefore, when themain body 11 is placed in the narrowed area of the airway, achannel 100 is formed inside themain body 11 and theelastic portion 13, serving as an airway passage.

于是，通过固定部分15，主体11被牢固地固定到变窄的区域。也就是，因为固定部分15从主体11的外侧以统一的距离向外突出，所以通过以固定部分15的突出区域紧紧地挤压气道的变窄的区域，支架10被牢固地固定到气道的变窄的区域。Then, themain body 11 is firmly fixed to the narrowed area by the fixingportion 15 . That is, since the fixingportion 15 protrudes outward at a uniform distance from the outer side of themain body 11, thebracket 10 is firmly fixed to the airway by tightly pressing the narrowed area of the air passage with the protruding area of the fixingportion 15. The narrowed area of the road.

如此，支架10被用于固定的状态，该状态下主体11通过固定部分15被固定。于是，当气道的组织生长时，生长的组织嵌入到位于固定部分15之间的间隔部分200内，从而把固定部分15牢固地固定到气道的变窄的区域。In this way, thebracket 10 is used in a fixed state in which themain body 11 is fixed by the fixingportion 15 . Then, when the tissue of the airway grows, the grown tissue is embedded in thespacer portion 200 between the fixingportions 15, thereby firmly fixing the fixingportion 15 to the narrowed area of the airway.

由于通道100与支架10的外表面完全隔离，它可以预防气道的组织嵌入到支架10内。Since thechannel 100 is completely isolated from the outer surface of thestent 10 , it prevents tissue of the airway from being embedded in thestent 10 .

如上所述，处于固定状态时，当气道的构型随气道阻塞病人剧烈咳嗽而变化的时候，弹性部分13就以如图4所示的预定曲率中心根据气道构型变化而折叠到主体11的内侧。As mentioned above, when in a fixed state, when the configuration of the airway changes with the severe cough of the patient with airway obstruction, theelastic part 13 will be folded according to the change of the airway configuration with the predetermined center of curvature as shown in Figure 4 The inner side of themain body 11.

当弹性部分13如此折叠的时候，主体11的外表面通常以椭圆形折叠，以便主体11以预定的曲率中心形成弹性部分13的外表面。When theelastic portion 13 is thus folded, the outer surface of themain body 11 is generally folded in an oval shape so that themain body 11 forms the outer surface of theelastic portion 13 with a predetermined center of curvature.

根据本发明的支架，即使气道的构型发生变化，主体11可以通过弹性部分13根据气道构型而被灵活的折叠，因此基于气道构型变化的压力并不作用于主体11。所以支架10的耐用性得到提高。According to the stent of the present invention, even if the configuration of the airway changes, themain body 11 can be flexibly folded according to the configuration of the airway through theelastic portion 13, so the pressure based on the change of the airway configuration does not act on themain body 11. Therefore, the durability of thestand 10 is improved.

同样，一旦本发明的支架需要被用于体腔例如气道的变窄的区域的细长和弯曲区域时，多个支架10可以按需要通过连接部分连接。Also, once the stent of the present invention is required to be used in elongated and curved regions of body lumens such as narrowed regions of airways, a plurality ofstents 10 can be connected by connecting portions as required.

以下，两个或三个支架的连接过程将被详细描述以给出连接过程的例子。然而，更多数目的支架可以使用同样的过程被连接。Hereinafter, the connection process of two or three brackets will be described in detail to give an example of the connection process. However, a greater number of brackets can be connected using the same process.

也就是，如图5和图6所示，另外的支架10的凸面连接元件19和20被安装到一个支架10的凹面连接元件17和18的内侧，凸面连接元件19的末端部分在凹面连接元件17的制动器23处被制动，于是凸面连接元件20与连接槽25结合，同时凹面连接元件18与凸面连接元件20的连接槽27结合。That is, as shown in FIGS. 5 and 6 , themale connecting elements 19 and 20 of anotherbracket 10 are mounted to the insides of thefemale connecting elements 17 and 18 of onebracket 10 , and the end portion of themale connecting element 19 is placed between the female connecting elements. Thebrake 23 of 17 is braked, so themale connecting element 20 is combined with the connectinggroove 25 , and the female connectingelement 18 is combined with the connectinggroove 27 of themale connecting element 20 .

如果这样，如图6所示，连接部分的凹面连接元件17的末端部分与固定部分15的末端部分紧密接触，并且凸面连接元件19的末端部分与凹面连接元件17和18内侧的末端部分，即制动器23和连接槽15紧密接触。这样，一个支架10被牢固地安装到另一支架10内并与其连接。If so, as shown in FIG. 6, the end portion of thefemale connection element 17 of the connection portion is in close contact with the end portion of the fixedportion 15, and the end portion of theconvex connection element 19 is in close contact with the end portions of theconcave connection elements 17 and 18, i.e. Thestopper 23 is in close contact with theconnection groove 15 . In this way, onebracket 10 is securely fitted into and connected to theother bracket 10 .

在处于如上所述的连接状态中时，当需要使支架10更长一些的时候，一个支架10的凸面连接元件19，20以如上所述同样的方式安装并连接到另一个支架10的凹面连接元件17，18。In the connected state as described above, when it is desired to make thesupport 10 longer, themale connection elements 19, 20 of onesupport 10 are mounted and connected to the female connection of theother support 10 in the same manner as described above.Elements 17, 18.

此外，当多个被如此连接的支架10被置于体腔例如气道的变窄的和弯曲的区域内，并且支架10的连接部分处于体腔弯曲区域位置时，支架10利用连接部分的凹面和凸面连接元件17，18，19和20的连接区域的弹性根据弯曲程度有效地折叠。In addition, when a plurality of thus connectedstents 10 are placed in a narrowed and curved region of a body cavity such as an airway, and the connecting portion of thestent 10 is at the position of the curved region of the body cavity, thestent 10 utilizes the concavity and convexity of the connecting portion The elasticity of the connecting regions of the connectingelements 17, 18, 19 and 20 effectively folds in accordance with the degree of bending.

图7至9显示如本发明的第二个实施例的支架，除了以下特征外与第一个实施例基本相同。7 to 9 show a stent according to a second embodiment of the present invention, which is basically the same as the first embodiment except for the following features.

如第二个实施例的支架10包括主体11，弹性部分13和固定部分。Thebracket 10 as in the second embodiment includes amain body 11, anelastic part 13 and a fixing part.

支架10包括固定凸耳21，该凸耳同固定部分一起用于把主体11牢固地固定到体腔的变窄的区域。具有预定形状和大小的固定凸耳21从固定部分的外表面向外突出。Thebracket 10 comprises fixinglugs 21 which, together with the fixing portion, serve to securely fix themain body 11 to the narrowed region of the body cavity. A fixinglug 21 having a predetermined shape and size protrudes outward from the outer surface of the fixing portion.

固定凸耳21可以以统一的或任选的间隔位于固定部分15的外表面，并且可以为圆形、椭圆形和正方形等等。The fixing lugs 21 may be located on the outer surface of the fixingportion 15 at uniform or optional intervals, and may be circular, elliptical, square, and the like.

并且，如图7所示，固定凸耳21可以以统一间隔和之字型沿纵向形成于主体的外表面上，以便将主体牢固地固定到体腔上。Also, as shown in FIG. 7, fixing lugs 21 may be formed at uniform intervals and in a zigzag shape on the outer surface of the main body in the longitudinal direction so as to securely fix the main body to the body cavity.

各种修饰和变化能够不偏离本发明的范围而运用到本发明的设备，这对于本领域的熟练技术人员是显而易见的。如果对于本发明的修饰和变化属于所附的权利要求及其等价物的范围，则本发明包括这些修饰和变化。It will be apparent to those skilled in the art that various modifications and variations can be applied to the device of the invention without departing from the scope of the invention. The present invention includes modifications and changes to the present invention if they fall within the scope of the appended claims and their equivalents.

Claims (12)

1, a kind of support that comprises main body, elastic part and a plurality of standing parts, wherein: described main body, can shrink under external force, and can be in expansion state naturally when being in the no load condition of no external force, this main body has predetermined length and shape; Described elastic part is connected to each other by the two ends main body, and this elastic part forms therebetween passage with main body, and makes main body adapt to the metamorphosis of body cavity neatly; Described a plurality of standing part is used for main body is fixed firmly to the change narrow region of body cavity, and standing part is formed on the outer surface of main body;

It is characterized in that this support also comprises the coupling part, be used for that a support is connected and keeps its characteristic with another support and need not the assistance of further processing, operation and equipment that this coupling part is formed at the end of support by predetermined size;

Wherein, described coupling part is formed at an end and the other end of a support, and the concave surface and the convex surface Connection Element that contain the other end that is useful on the end that connects a support respectively and another support, the inner surface of the concave surface Connection Element of coupling part has brake, this brake is used to stop the end of concave surface Connection Element to the convex surface Connection Element, so that prevention convex surface Connection Element moves to the inboard of the concave surface Connection Element that is in couple state, this couple state is that the convex surface Connection Element of other support combines with the concave surface Connection Element of a support.

2, the support of claim 1, wherein the cross section of main body forms semicircle or circle.

3, the support of claim 1, wherein the cross section of main body is formed so that elastic part is easy to according to the change of airway form fold with C shape structure.

4, the support of claim 1, wherein elastic part has the thickness identical or different with the thickness of main body.

5, the support of claim 1, wherein elastic part has identical or different thickness along its width.

6, the support of claim 1, wherein the thickness of elastic part is less than the thickness of main body.

7, the support of claim 1, wherein elastic part is folding with the center of radius identical with main body according to the variation of body cavity form.

8, the support of claim 1, wherein standing part protrudes in whole or the part circumferential surface along the circumferencial direction of main body, so that securely main body is fixed to the zone that narrows down of body cavity.

9, the support of claim 1, wherein interval region is formed between the standing part, main body be inserted into body cavity narrow down the zone in the time, by the embedding bodily cavity tissue main body is fixed firmly to body cavity.

10, the support of claim 1 comprises further being used for standing part main body being fixed firmly to the attaching clamp in the zone that body cavity narrows down that this attaching clamp protrudes in the outer surface of standing part.

11, the support of claim 1, wherein the interior diameter of the convex surface Connection Element of coupling part has and main body and the essentially identical diameter of elastic part, and the overall diameter of the interior diameter of concave surface Connection Element and convex surface Connection Element is basic identical.

12, claim 1 or 11 support, wherein the inner surface of concave surface Connection Element has the groove of connection with the outer surface of convex surface Connection Element, this connection groove is used for respectively convex surface and concave surface Connection Element being attached to concave surface and the convex surface Connection Element that is in couple state, and concave surface and convex surface Connection Element are bonded to each other in this couple state.

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